West Windsor vaccine company CEO talks about the business' present and future

Michael Mancuso/The TimesChristopher J. Schaber, PhD, president and CEO of Soligenix, a company working to develop vaccines against biological attacks, speaks with Times reporter Joshua Rosenau.

WEST WINDSOR — Christopher Schaber knows about the difficulties of pharmaceutical development as president and CEO of Soligenix, a vaccine and drug maker.

Last year the company’s stock sank after it announced that trials of an oral drug it was developing for gastrointestinal disease had shown little potential.

Following the slump, Schaber has had to refocus the priorities of the Emmons Drive company, relying on prior experience and expertise to find new paths to success.

In late 2011, Soligenix announced it was partnering with Harvard University to stabilize an anthrax vaccine so it can be stored for long periods without losing its potency. The company is also working to develop a steroid to treat inflammatory bowel disease and acute radiation syndrome.

A scientist by training, Schaber’s believes even a negative result provides good information.

Long after the Anthrax scare that hit Mercer seems to have been resolved, Soligenix continues to work on a vaccine. How strong is this initiative and the government’s commitment to this project?

When you talk about our history, we are a company that was founded in 1987. Like many biotech companies that have taken on different forms and really adjusted their portfolios, we started out as a drug delivery type of company, then transitioned to more of a gastrointestinal and oncology setting. Then after 9/11 we really injected the vaccine component into our business.

This was really driven by our expertise in the vaccine area, which made it a little bit easier to go after government grant monies, and the need.

What makes it worthwhile to work on these specific projects?

One thing about our ricin toxin vaccine is that it is extremely volatile, as a liquid. So you need to maintain very strict refrigeration conditions or it will start to degrade. So we identified a freeze drying technology called ThermoVax that we coupled with our ricin vaccine to show that, once we freeze dry this particular vaccine, you can keep it in excess of 40 degrees Celsius without any degradation at all. So that may have applications for a number of targeted vaccines as well as companies developing new vaccines.

There was a recent report put out by DHS about the storage of pediatric vaccines, and it showed that a number of these vaccines are not kept at proper storage conditions and it jeopardizes the potency of the vaccine or its shelf life.

The technology that we have now has the potential to correct some of that. It’s very early, but we’re in the process of collecting some initial data and then going out to some of these companies and seeing if they want to collaborate with us to help stabilize their vaccines.

Will this attention to the storage and delivery of vaccines help you to improve responses to natural disasters?

We are. That’s why we are trying to match the qualities of this ThermoVax vaccine with vaccines that we have the highest likelihood of stabilizing. If you think about our own troops and you know that they might be exposed to anthrax or ricin toxin, those vaccines require refrigeration. So if you’re in Afghanistan or Iraq and you have to think about transporting and maintaining vaccines in large quantities of them there is a level of complexity there that a room-temperature vaccine can resolve.

Based on what government has shown, what the World Health Organization has released, as well as other government bodies, there is a need to stabilize these vaccines. That need exists, not only for our own country, but for vaccines going to the emerging and developing world.

There you have refrigeration that is so expensive and that is difficult to maintain.
What needs to happen to develop effective vaccines for these two deadly agents? What stage of development are the vaccines in? How far are we from effective solutions?
You can use established animal models of the disease and then treat there to prove efficacy. Then you prove that the drug is safe for humans.

Just looking at anthrax, you have to establish a model of anthrax exposure, and the FDA wants to see a number of models. They don’t want just to see mice, because that’s not indicative. They want you to show it in mice, in an intermediary like a dog, all the way up to non-human primates. And then once you establish the efficacy of that vaccine, you take that vaccine and inject into humans to show that it is safe.

I have had people call me and say, “I don’t believe that you’re doing that to animals,” and I say, “Well you have to show it works somehow before you give it to a human, what would you have me do?” You need to show it’s safe. You need to show it works. Unless you think you should be exposing people to ricin and anthrax, how do you expect to show that?

That’s always the difficulty with the biodefense side. It’s an area that, even after more than 10 years, is still evolving to try and find the best animal models for anthrax.

How have the anthrax and ricin projects helped Soligenix’s bottom line?

The government made a considerable sum of money available for those that wanted to develop vaccines in the biodefense field, and we thought it was a wise thing to go after some of those grants in order to keep our company growing. It also helped raise money and not have to go to Wall Street to investors to try and get considerable amounts of money to defray some of our expenses.

What’s the status of Soligenix’s other drug candidates?

Our therapy for acute radiation syndrome has lagged a little bit in the development model from anthrax and ricin. Those were the big hits, because that’s what everybody heard post-9/11, and our post office here in Hamilton with the anthrax. So there was a focus there.

The acute radiation syndrome (treatment) was a late-comer, and the animal models are still being developed to find out what’s the right level of radiation exposure needed to show that a drug is working. Plus it’s multi-faceted. How do you parse out the particular drugs to treat just one area of that syndrome, ultimately there’s going to have to be a cocktail to treat people depending on the level of exposure.

So, does this make the vaccines the company’s best hope for the future?

On the vaccine side, especially with biodefense, there is that political climate that is a little more responsive in saying, “Hey, we need these countermeasures.”

But these grant processes, they take a long period of time. Sometimes you submit a grant, and sometimes you’re going against 50 or 100 others at times, and you won’t hear for another 10 months later that you were actually awarded.

If you’re not awarded, then what do you do? There’s not a market for biodefense. You can’t just say this is the patient population. This is what we’re treating. You’re anticipating how to treat something that comes out of some kind of catastrophic event, and because of that, out on Wall Street, there is not a lot of support for biodefense.

That is why the government interest is so important to develop that.

Once you develop the vaccine, you can start procuring government contracts that could be very large, in the hundreds of millions of dollars. That’s when Wall Street looks at it and says, “There’s value there,” but until then, it’s a long road.